INFLAMMATION - bacillus anthracis immunoserum rabbit, rancid beef, aconitum napellus, aloe, apis mellifera, arnica montana, arsenic trioxide, baptisia tinctoria root, atropa belladonna, bryonia alba root, lytta vesicatoria, chelidonium majus, crotalus horridus horridus venom, ferrosoferric phosphate, gaultheria procumbens top, calcium sulfide, iodine, lachesis muta venom, strychnos nux-vomica seed, phosphorus, pulsatilla vulgaris, toxicodendron pubescens leaf, veratrum viride root, verbascum thapsus and echinacea, unspecified liquid
Newton Laboratories, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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INDICATIONS & USAGE SECTION

Inflammation Formulated for associated symptoms such as pain, swelling, allergic reactions, congestion and joint problems.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Anthracinum 30x, Pyrogenium 30x, Aconitum nap. 15x, Aloe 15x, Apis mel. 15x, Arnica 15x, Arsenicum alb. 15x, Baptisia 15x, Belladonna 15x, Bryonia 15x, Cantharis 15x, Chelidonium majus 15x, Crotalus horridus 15x, Ferrum phosphoricum 15x, Gaultheria procumbens 15x, Hepar sulph. calc. 15x, Iodium 15x, Lachesis 15x, Nux vom. 15x, Phosphorus 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Veratrum viride 15x, Verbascum 15x, Apis mel. 3x, Echinacea 3x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as pain, swelling, allergic reactions, congestion and joint problems.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.

QUESTIONS SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

PACKAGE LABEL

INFLAMMATION
anthracinum, pyrogenium, aconitum nap., aloe, apis mel., arnica, arsenicum alb., baptisia, belladonna, bryonia, cantharis, chelidonium majus, crotalus horridus, ferrum phosphoricum, gaultheria procumbens, hepar sulph. calc., iodium, lachesis, nux vom., phosphorus, pulsatilla, rhus toxicodendron, veratrum viride, verbascum, echinacea liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-2300
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Bacillus Anthracis Immunoserum Rabbit (Bacillus Anthracis Immunoserum Rabbit)	Bacillus Anthracis Immunoserum Rabbit	30 [hp_X] in 1 mL
Rancid Beef (Rancid Beef)	Rancid Beef	30 [hp_X] in 1 mL
Aconitum Napellus (Aconitum Napellus)	Aconitum Napellus	15 [hp_X] in 1 mL
Aloe (Aloe)	Aloe	15 [hp_X] in 1 mL
Apis Mellifera (Apis Mellifera)	Apis Mellifera	15 [hp_X] in 1 mL
Arnica Montana (Arnica Montana)	Arnica Montana	15 [hp_X] in 1 mL
Arsenic Trioxide (Arsenic Cation (3+))	Arsenic Trioxide	15 [hp_X] in 1 mL
Baptisia Tinctoria Root (Baptisia Tinctoria Root)	Baptisia Tinctoria Root	15 [hp_X] in 1 mL
Atropa Belladonna (Atropa Belladonna)	Atropa Belladonna	15 [hp_X] in 1 mL
Bryonia Alba Root (Bryonia Alba Root)	Bryonia Alba Root	15 [hp_X] in 1 mL
Lytta Vesicatoria (Lytta Vesicatoria)	Lytta Vesicatoria	15 [hp_X] in 1 mL
Chelidonium Majus (Chelidonium Majus)	Chelidonium Majus	15 [hp_X] in 1 mL
Crotalus Horridus Horridus Venom (Crotalus Horridus Horridus Venom)	Crotalus Horridus Horridus Venom	15 [hp_X] in 1 mL
Ferrosoferric Phosphate (Ferrosoferric Phosphate)	Ferrosoferric Phosphate	15 [hp_X] in 1 mL
Gaultheria Procumbens Top (Gaultheria Procumbens Top)	Gaultheria Procumbens Top	15 [hp_X] in 1 mL
Calcium Sulfide (Calcium Sulfide)	Calcium Sulfide	15 [hp_X] in 1 mL
Iodine (Iodine)	Iodine	15 [hp_X] in 1 mL
Lachesis Muta Venom (Lachesis Muta Venom)	Lachesis Muta Venom	15 [hp_X] in 1 mL
Strychnos Nux-vomica Seed (Strychnos Nux-vomica Seed)	Strychnos Nux-vomica Seed	15 [hp_X] in 1 mL
Phosphorus (Phosphorus)	Phosphorus	15 [hp_X] in 1 mL
Pulsatilla Vulgaris (Pulsatilla Vulgaris)	Pulsatilla Vulgaris	15 [hp_X] in 1 mL
Toxicodendron Pubescens Leaf (Toxicodendron Pubescens Leaf)	Toxicodendron Pubescens Leaf	15 [hp_X] in 1 mL
Veratrum Viride Root (Veratrum Viride Root)	Veratrum Viride Root	15 [hp_X] in 1 mL
Verbascum Thapsus (Verbascum Thapsus)	Verbascum Thapsus	15 [hp_X] in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified)	Echinacea, Unspecified	3 [hp_X] in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Alcohol

Packaging
#	Item Code	Package Description
1	NDC:55714-2300-1	29.57 mL in 1 BOTTLE, GLASS
2	NDC:55714-2300-2	59.14 mL in 1 BOTTLE, GLASS
3	NDC:55714-2300-0	.5 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/01/2011

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	MANUFACTURE(55714-2300), API MANUFACTURE(55714-2300)

Revised: 03/2011

Document Id: 5512488a-c44c-17ed-98ce-80ae90b7c591

Set id: 2918807a-2ee0-a025-7fd1-76d3600afb32

Version: 1

Effective Time: 20110301

Newton Laboratories, Inc.